Services
How we can help you
- Analytical Validation
- Study design, data analysis, and reports according to regulatory guidelines
- Regulatory submission
- Assay launch
- Publications based on clinical trials and utility studies
- Clinical Validation
- Bridging study
- External concordance study
- Regulatory Submission
- Prepare submission package
- Interacting with FDA/CLIA
- Algorithm Development and Analytical Validation
- Exploratory biomarker development based on different assay technologies
- Strategic planning the use of specimens and data
- Experimental design data analysis according to regulatory recognized guidelines
- Algorithm development via data mining and Bioinformatics approaches
- Regulatory submission
- Clinical Validation
- Clinical trial design, strategic planning on the use of data sources
- Statistical Analysis Plan (SAP) development
- Data analysis and report
- Publication and submission support
- Clinical trial design and statistical analysis methodologies
- Protocol and statistical analysis plan (SAP) development, design of tables, listings and figures (TLFs)
- Interim analyses (re-estimation of sample size, dose escalation decision) and final analyses
- Design of CRFs and specifications for the creation of ADAM datasets
- Provide programming specifications (in CDISC format)
- Support of publications and submissions
- PK data analysis using compartmental and non-compartmental models
- Immunogenicity assays
- Assay optimization and assay validation
- Cutpoint determination for screening, confirmation, titer, and NAb assays
- Associations between biomarker, PK, PD, Immunogenicity results
- Drug Target Identification integrating internal and external data
- Microarray expression data analysis
- Exploratory research using statistics and bioinformatics approaches
- Molecular characterization of disease and drug mechanisms with data mining
- In vitro and animal studies
- HTS assay development, lead identification and optimization
- In vivo efficacy and toxicity studies
- Experience in different assay technologies – microarray, PCR, GWAS, Proteomics, High content imaging, and a variety of immunoassays
- CMC
- Bioinformatics
- IND submission
- Data mining, pattern recognition
- Predictive model development
- Statistical inferences
- Publication support
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